# K022654: Modification to Elecsys CK-MB Stat, Elecsys CK-MB

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 29, 2002 after 20 days
- Product code: JHY (Colorimetric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931172 (1993). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974421: Elecsys CK-MB Stat, Boehringer Mannheim Corp. (1997) Summary page 2.

## Most influential descendants
- K132571: Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay (2013), 1 descendant of its own
- K140404: Elecsys CK-MB Stat Immunoassay (2014), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers. Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

Source page: https://510kreport.com/device/K022654
Methodology: https://510kreport.com/methodology